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STOP-HAE: A Phase 3 Study of ADX-324 in HAE

Study acronym: STOP-HAE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jun 30, 2027 → Nov 30, 2027
See other at-risk trials from ADARx Pharmaceuticals, Inc.

Record History

  1. Primary completion pushed from Jun 30, 2027 to Nov 30, 2027 Trial sites expanded: 51 → 70 locationsv13 Show 1 more changeShow less
    • Trial sites expanded: 51 → 70 locations
  2. Re-verified, no change to tracked fieldsv12
  3. Study sites: 50 to 51v11
  4. Site details revised at 1 of 50 sitesv10
  5. Trial sites expanded: 14 → 50 locationsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Re-verified, no change to tracked fieldsv8
  2. Eligibility criteria shortened, about 179 words Study description shortened, about 48 wordsv7 Show 1 more changeShow less
    • Study description shortened, about 48 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Dec 31, 2026 to Jun 30, 2027 Primary endpoint revised · Study sites: 1 to 14 · Completion date: Dec 31, 2026 to Dec 31, 2027 · 3 morev6 Show 6 more changesShow less
    • Primary endpoint revised
    • Study sites: 1 to 14
    • Completion date: Dec 31, 2026 to Dec 31, 2027
    • Eligibility criteria shortened, about 507 words
    • Secondary endpoints: 9 to 5
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Start date changed from estimate of Jul 1, 2025 to Aug 28, 2025v5
  5. Trial status: Not Yet Recruiting to Recruiting Start date: May 31, 2025 to Jul 1, 2025 · Study sites: 0 to 1 · Eligibility criteria shortened, about 39 wordsv4 Show 3 more changesShow less
    • Start date: May 31, 2025 to Jul 1, 2025
    • Study sites: 0 to 1
    • Eligibility criteria shortened, about 39 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study description expanded, about 49 words Study title shortened, about 21 wordsv3 Show 1 more changeShow less
    • Study title shortened, about 21 words

    See this version in full on ClinicalTrials.gov ↗

  7. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will evaluate the efficacy and safety of ADX-324 in participants with Type 1 or Type 2 hereditary angioedema. The study will also evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD), and health-related quality of life measures.
Trial Details
NCT Number NCT06960213
Lead Sponsor ADARx Pharmaceuticals, Inc.
Conditions Hereditary Angioedema, HAE, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov